Category - NIS Directive

medicaldeviceslegal

End of year bonanza

Normally one looks back at the end of the year, but I also like to look ahead because there are a lot of developments in EU law that will affect the medical devices industry next year: new rules on cybersecurity, data protection, mHealth and business compliance will put their mark on 2016, additional to the never-ending […]

medicaldeviceslegal

More on EU medical devices cybersecurity regulation

In a previous post I promised more on cybersecurity, so here it is. Spoiler alert: the conclusion of this post is that cyber security requirements for medical devices in Europe are currently an overlapping patchwork of different statutes with little attention for system and network security. So the conclusion is: there is nothing specific, except […]